510(k) · Cleared
Cleared3DFIS, Model Ies-FL-101
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3Dsharp, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 17, 2002 after a 58-day review. The FDA summary names no predicate by number. 16 later devices descend from it.
- Decided
- Jan 17, 2002
- Review
- 58 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK013841 3DFIS, Model Ies-FL-1013Dsharp, Inc. · 2002
- Descendant · cites it directly · 15 of its ownK123226 LessraySaferay Spine, LLC · 2012
- Descendant · 2 generations on · 14 of its ownK132970 LessraySaferay Spine, LLC · 2013
- Descendant · 2 generations on · 13 of its ownK142243 LessRay with TrackingSaferay Spine, LLC · 2014
- Descendant · 3 generations on · 12 of its ownK170800 NuVasive LessRay with Enhanced TrackingNu Vasive, Incorporated · 2017
- Descendant · 3 generations on · 4 of its ownK173314 LessRay SystemNu Vasive, Incorporated · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K123226LessraySaferay Spine, LLC · 2012 · cites it directly15descendants
- K132970LessraySaferay Spine, LLC · 2013 · 2 generations on14descendants
- K142243LessRay with TrackingSaferay Spine, LLC · 2014 · 2 generations on13descendants
- K170800NuVasive LessRay with Enhanced TrackingNu Vasive, Incorporated · 2017 · 3 generations on12descendants
- K173314LessRay SystemNu Vasive, Incorporated · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013841 | 3DFIS, Model Ies-FL-101 | 3Dsharp, Inc. | 2002 | — |
| +1 | K123226 | Lessray | Saferay Spine, LLC | 2012 | — |
| +2 | K132970 | Lessray | Saferay Spine, LLC | 2013 | — |
| +2 | K142243 | LessRay with Tracking | Saferay Spine, LLC | 2014 | — |
| +3 | K170800 | NuVasive LessRay with Enhanced Tracking | Nu Vasive, Incorporated | 2017 | — |
| +3 | K173314 | LessRay System | Nu Vasive, Incorporated | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123226 | Lessray | 2012 | 15 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K123226 (Saferay Spine, LLC, 2012) has gone furthest, with 15 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The 3DFIS is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013841 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013841: 3DFIS, Model Ies-FL-101.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013841
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026